FDA-Device2021-12-15Class I
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Covidien Llc
Hazard
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Sold states
Worldwide distribution - US Nationwide.
Affected count
278 total
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2022Don't want to check this manually?
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